Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery

Description

The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.

Conditions

Corneal Ectasia

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Study Overview

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Study Details

Study overview

The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.

A Phase IV Observational Registry to Assess the Safety and Durability of Effect of Corneal Collagen Cross-linking With Photrexa Viscous, Photrexa, and the KXL System in Patients With Corneal Ectasia Following Refractive Surgery

Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery

Condition
Corneal Ectasia
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University School of Medicine, Palo Alto, California, United States, 94303

Bloomington

Chu Vision Institute, P.A., Bloomington, Minnesota, United States, 55420

Bozeman

Vance Thompson Vision - MT, Bozeman, Montana, United States, 59718

W. Fargo

Vance Thompson Vision - ND, W. Fargo, North Dakota, United States, 58078

Westerville

Comprehensive EyeCare of Central Ohio, Westerville, Ohio, United States, 43082

Bala-Cynwyd

Vantage Eye Care, LLC, Bala-Cynwyd, Pennsylvania, United States, 19004

Ladson

Carolina Cataract & Laser Center, Ladson, South Carolina, United States, 29456

Houston

Slade & Baker Vision, Houston, Texas, United States, 77027

Draper

Hoopes Vision, Draper, Utah, United States, 84020

McLean

See Clearly Vision Group, McLean, Virginia, United States, 22102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Be at least 18 years of age, male or female, of any race;
  • 2. Provide written informed consent and sign a HIPAA form;
  • 3. Willingness and ability to follow all instructions and comply with schedule for study visits;
  • 4. Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
  • 5. Planning to undergo (or have undergone within the past 90 days) corneal collagen cross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribing information (NOTE: Complete treatment and follow-up data, including any product-related events at time of procedure through the time of enrollment must be available);
  • 6. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to enrolling in the registry; must not be pregnant or lactating.
  • 1. If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
  • 2. The Investigator may exclude or discontinue any patient for any sound medical reason.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Glaukos Corporation,

Kerry Stephens, STUDY_DIRECTOR, Glaukos Corporation

Study Record Dates

2026-02